ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-23429
- Event Type
- Malfunction
- Date Received
- April 11, 2024
- Date of Event
- March 21, 2024
- Report Date
- May 9, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2718-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.
A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[MMS-20-3991 LVP KEYPAD REPLACEMENT P4 MMS-20-1953 SOFTWARE RECALL V12.1.1 MMS-21-4100 BROKEN BEZEL MMS-20-3817 LVP KEYPAD REPLACEMENT P2]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[MMS-20-3991 LVP KEYPAD REPLACEMENT P4 MMS-20-1953 SOFTWARE RECALL V12.1.1 MMS-21-4100 BROKEN BEZEL MMS-20-3817 LVP KEYPAD REPLACEMENT P2]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[MMS-20-3991 LVP KEYPAD REPLACEMENT P4, MMS-20-1953 SOFTWARE RECALL V12.1.1, MMS-21-4100 BROKEN BEZEL, MMS-20-3817 LVP KEYPAD REPLACEMENT P2]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1333871 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |